Xeloda

Xeloda is used to help treat patients with Dukes' C colon cancer (colon cancer that has spread to lymph nodes in the area close to the colon), after having surgery. This medicine is also used to treat metastatic colorectal cancer (cancer of the colon or rectum that has spread to other parts of the body).

Capecitabine is also used together with docetaxel to treat metastatic breast cancer (breast cancer that has spread to other parts of the body) in patients who have received other medicines (eg, paclitaxel) but did not work well, or in patients who cannot receive cancer medicines anymore.

Capecitabine belongs to the group of medicines called antineoplastics (cancer medicines). It interferes with the growth of cancer cells, which are eventually destroyed by the body.

Since the growth of normal cells may also be affected by the medicine, other side effects may also occur. Some of these may be serious and must be reported to your doctor.

This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling,

Xeloda is used in certain patients with the following medical conditions:

• Advanced or metastatic stomach cancer (cancer that has spread to other areas of the body), first-line therapy.
• Metastatic colorectal cancer (cancer of the colon or rectum that has spread to other areas of the body), first-line therapy, in combination with bevacizumab and oxaliplatin.
• Gastric cancer (stomach cancer), stage II to IIIB, in combination with oxaliplatin.
• Rectal cancer (cancer of the rectum), locally advanced, adjuvant or neoadjuvant therapy, in combination with radiation therapy.

This product is available in the following dosage forms:

• Tablet

Before using Xeloda, you must know all about the risks and complications associated with it. This is a decision you and your doctor will make.

For this medicine, the following should be considered:

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric Population: Appropriate studies have not been performed on the relationship of age to the effects of capecitabine in the pediatric population. Safety and efficacy have not been established.

Geriatric Population: Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of capecitabine in the elderly.

However, elderly patients are more likely to have unwanted side effects (eg, severe diarrhea, nausea or vomiting, hand-and-foot syndrome) or age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving capecitabine.

Pregnancy: Category D: Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breastfeeding: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary.

When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rotavirus Vaccine, Live
• Tegafur

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol, Adenovirus Vaccine Type 4, Live, Adenovirus Vaccine Type 7, Live, Azanidazole
• Bacillus of Calmette and Guerin Vaccine, Live, Benznidazole
• Cimetidine
• Influenza Virus Vaccine, Live, Isoconazole
• Measles Virus Vaccine, Live, Methotrexate, Metronidazole, Mumps Virus Vaccine, Live
• Nimorazole
• Ornidazole
• Phenprocoumon, Poliovirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Secnidazole, Smallpox Vaccine
• Tamoxifen, Tinidazole, Typhoid Vaccine
• Varicella Virus Vaccine
• Warfarin
• Yellow Fever Vaccine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Fosphenytoin
• Leucovorin, Levamisole, Levoleucovorin
• Phenytoin
• Thiamine

Other Interactions: Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems: The presence of other medical problems may affect the use of this medicine.

Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to 5-fluorouracil 
• Kidney disease, severe 
• Shortage of an enzyme called dihydropyrimidine dehydrogenase (DPD) that your body needs—Should not be used in patients with these conditions
• Coronary heart disease, history of—May cause side effects to become worse
• Dehydration 
• Kidney disease, mild or moderate 
• Liver disease—Use with caution. May make these conditions worse
• Infection—May decreases your body's ability to fight infection

Proper usage of Xeloda requires strict adherence to your doctor’s orders. Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions. Take this medicine with food or within 30 minutes after you eat. Swallow the tablet whole with water. Do not cut, crush, break, or chew it.

Dosing: The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets)
• For metastatic breast and colorectal cancer:
• For patients receiving this medicine alone

Adults—Dose is based on body size and must be determined by your doctor. At first, 2500 milligrams (mg) per square meter (m(2)) of body size per day, divided into 2 doses and taken about 12 hours apart. These doses are taken for 2 weeks, followed by 1-week rest, given as 3 weeks cycle. Your doctor may adjust your dose if needed.

Children—Use and dose must be determined by your doctor.

For patients receiving this medicine with docetaxel:

Adults—Dose is based on the body surface and must be determined by your doctor. At first, 2500 milligrams (mg) per square meter (m(2)) of body surface area per day, divided into 2 doses and taken about 12 hours apart. These are taken for 2 weeks, followed by 1-week rest, given as 3 weeks cycle Your doctor may adjust your dose if needed.

Children—Use and dose must be determined by your doctor.

Missed Dose: If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage: Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use.

Before using Xeloda, there are some precautions you must take. It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Your doctor may request that you have a test to determine if your blood is clotting properly, and may perform this test frequently if you are also taking a blood thinner.

Pregnancy: Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. Tell your doctor right away if you think you have become pregnant.

Heart Problems: This medicine may cause heart problems. Check with your doctor right away if you have chest pain that may spread to your arms, jaw, back, or neck, faintness, nausea, swelling in your hands, ankles, or feet, trouble breathing, or unusual sweating.

Check with your doctor right away if any of the following symptoms occur:

• Diarrhea, moderately severe (four to six stools a day more than usual, or during the night).
• Nausea that is severe enough to cause you to eat less than usual.
• Vomiting two or more times in a 24-hour period.
• Pain and redness, swelling, or sores or ulcers in your mouth or on your lips that are severe enough to interfere with eating.

If vomiting occurs less often than mentioned above, or if nausea does not cause you to eat less than usual, it is not necessary for you to stop taking the medicine or to check with your doctor (unless these effects are particularly bothersome).

Also, you do not need to stop taking the medicine if diarrhea occurs less often than mentioned above or if the other side effects listed are not severe enough to interfere with eating or other daily activities. However, check with your doctor as soon as possible if they occur.

Skin Reactions: Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling or loose skin, red skin lesions, pain, swelling, or blisters on the palms of your hands or soles of your feet, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

Immunization: While you are being treated with Capecitabine, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval.

Capecitabine may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you.

Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Capecitabine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting.

If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

As with many medications, there are several potential side effects associated with Xeloda. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common:

• abdominal or stomach pain
• diarrhea
• nausea
• numbness, pain, tingling, or other unusual sensations in the palms of the hands or bottoms of the feet
• pain, blistering, peeling, redness, or swelling of the palms of the hands or bottoms of the feet
• pain, redness, swelling, sores, or ulcers in your mouth or on your lips
• unusual tiredness or weakness
• vomiting

Less common or rare:

• abdominal or stomach cramping or pain (severe)
• agitation
• back pain
• bleeding and bruising
• bleeding gums
• blood in the urine or stools
• bloody nose
• bloody or black, tarry stools
• blurred vision
• burning, dry, or itching eyes
• chest pain
• chills
• clumsiness or unsteadiness
• cold
• collapse
• coma
• confusion
• constipation
• convulsions
• cough or hoarseness (accompanied by fever or chills)
• cough producing mucus
• coughing or spitting up blood
• dark urine
• decreased frequency or amount of urine
• difficulty with breathing
• difficulty with swallowing or pain in the back of throat or chest when swallowing
• discharge from the eyes
• drowsiness
• dry mouth
• excessive tearing
• extra heartbeats
• eye redness, irritation, or pain
• fainting
• fast or irregular heartbeat
• fever or chills
• flu-like symptoms
• hallucinations
• headache, sudden and severe
• heavier menstrual periods
• high fever
• hot, red skin on the feet or legs
• inability to speak
• increased menstrual flow or vaginal bleeding
• increased thirst
• irritability
• itching in the genital or other skin areas
• lightheadedness
• light-colored stools
• loss of consciousness
• lower back or side pain (accompanied by fever or chills)
• muscle aches or cramps
• muscle spasms
• nosebleeds
• numbness or tingling in the hands, feet, or lips
• painful or difficult urination (accompanied by fever or chills)
• painful, swollen feet or legs
• pain, tenderness, or swelling in the upper abdominal or stomach area
• pale skin
• paralysis
• pinpoint red spots on the skin
• problems with coordination
• prolonged bleeding from cuts
• rapid, shallow breathing
• red or dark brown urine
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• scaling
• seizures
• severe constipation
• skin rash or itching
• slow or irregular heartbeat
• slurred speech
• sneezing, sore throat, or stuffy nose
• sores, ulcers, or white spots on the lips or in the mouth
• stiff neck
• stomach bloating, burning, or cramping
• swelling of the face, fingers, feet, or lower legs
• swelling of the lymph nodes
• swollen glands
• temporary blindness
• tiredness or weakness
• trouble with speaking
• troubled breathing or tightness in the chest
• unexplained nosebleeds
• unusual bleeding or bruising
• unusual lump or swelling in the chest
• vomiting blood or material that looks like coffee grounds
• weakness in the arm or leg on one side of the body, sudden and severe
• weight gain or loss
• white patches in the mouth or throat or on the tongue
• white patches with diaper rash
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common:

• burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• changes or discoloration in the fingernails or toenails
• difficulty with moving
• discouragement
• dizziness
• headache
• heartburn
• increased sensitivity of the skin to sunlight
• muscle pain
• pain
• pain and redness of the skin at the place of x-ray treatment
• pain in the joints or limbs
• red, sore eyes
• sunken eyes
• thirst
• trouble sleeping
• weakness
• wrinkled skin

Rare:

• bone pain
• change in color of treated skin
• difficulty with walking
• discouragement
• feeling of constant movement of self or surroundings
• feeling sad or empty
• full or bloated feeling or pressure in the stomach
• general feeling of discomfort or illness
• hot flushes
• impaired balance
• increased sweating
• joint pain
• lack of appetite
• loss of interest or pleasure
• muscle weakness
• noisy breathing
• pain in the rectum
• pain, swelling, or redness in the joints
• passing less gas
• rough, scratchy sound to voice
• runny nose
• sensation of spinning
• shakiness in the legs, arms, hands, or feet
• shivering
• sores on the skin
• swelling of abdominal or stomach area
• tremor or shaking of the hands or feet
• trouble concentrating
• voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.